BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Venus Viva applicator

    DI: 07290016540321 · Model: AS110011 · VENUS CONCEPT LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Venus Viva applicator
    Primary DI
    07290016540321
    Version / Model
    AS110011
    Company Name
    VENUS CONCEPT LTD
    Labeler DUNS
    533127663
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    4
    Public Version Date
    2020-06-12
    Public Version Status
    Update
    Public Device Record Key
    90b54e64-74a0-47c2-9ce4-4fc000446682

    Device Description

    Venus Viva applicator is designed for use in dermatological procedures requiring ablation and resurfacing of the skin.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    GMDN Terms

    Code Name
    45213 Radio-frequency skin contouring system applicator, bipolar

    Identifiers

    Type ID
    Package 07290016540376
    Primary 07290016540321

    Premarket Submissions

    Submission Number Supplement Number
    K150161 000
    K191065 000